Comparison of Calcium Silicate-based Sealer and Epoxy Resin-based Sealer

NCT ID: NCT05904184

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

Brief Summary

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Background: Sealers have been concerned with obturation. However, studies for assessing the effectiveness of endodontic treatment of sealer based on Calcium Silicate have been not much.

Objective: This study aimed to assess the effectiveness of endodontic treatment of sealer based on Calcium Silicate Methods: A prospective, single-blind, clinical trial was conducted from June 2020 to December 2020 with 42 irreversible pulpitis teeth by one clinician. The postoperative pain was assessed after root canal treatment using sealer based on Calcium Silicate and sealer based on Epoxy resin after 6 hours, 12 hours, 24 hours, 48 hours, 72 hours and 7 days and inconvenient symptoms were assessed after 7 days, 3 months and 6 months. t-test, Mann-Whitney and Wilcoxon analysis were applied.

Key words: obturation, sealer based on Calcium Silicate and sealer based on Epoxy resin

Detailed Description

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Conditions

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Pulpitis - Irreversible Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Epoxy resin-based sealers (ERS)

After root canal preparation, canal obturation was performed with Epoxy resin-based sealers (ERS)

Group Type ACTIVE_COMPARATOR

Calcium silicate-based sealers (CSS)

Intervention Type DRUG

All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Calcium silicate-based sealers.

calcium silicate-based sealers (CSS)

After root canal preparation, canal obturation was performed with Calcium silicate-based sealers (CSS)

Group Type ACTIVE_COMPARATOR

Epoxy resin-based sealers (ERS)

Intervention Type DRUG

All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Epoxy resin-based sealers.

Interventions

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Epoxy resin-based sealers (ERS)

All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Epoxy resin-based sealers.

Intervention Type DRUG

Calcium silicate-based sealers (CSS)

All teeth received one-visit endodontic treatment according to the treatment protocol of the Vietnamese Ministry of Health with the support of three-dimensional imaging equipment and an endodontic machine. After root canal preparation, obturation was performed using Calcium silicate-based sealers.

Intervention Type DRUG

Other Intervention Names

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Epoxy resin-based cement Calcium silicate-based cement

Eligibility Criteria

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Inclusion Criteria

* aged 18 years or older
* teeth diagnosed with irreversible pulpitis by electrical and thermal tests (+)
* had clinical symptoms like continuous or spontaneous pain, teeth exposed to sudden temperature changes, especially cold stimuli, causing sharp pain and persisting after stimulus removal
* these teeth must have healthy periodontal tissue and sufficient clinical teeth crown for isolation with a rubber dam

Exclusion Criteria

Patients with:

* Pregnant
* Have a systemic disease requiring antibiotics or have an allergic reaction
* Have maxillofacial pathology, cellulitis, occlusal trauma, and temporomandibular disorders, have endodontic periodontal lesions, periodontal abscesses
* Have taken a previous pain reliever within 24 hours

Tooth:

* Roots internally or externally resorbed, cracked or broken
* Have had failed endodontic treatment, or the root canal cannot be controlled for leakage
* No opposing teeth
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Tran Ngoc Minh Duyen

University Post Graduated Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.

Reference Type BACKGROUND
PMID: 17956561 (View on PubMed)

El Mubarak AH, Abu-bakr NH, Ibrahim YE. Postoperative pain in multiple-visit and single-visit root canal treatment. J Endod. 2010 Jan;36(1):36-9. doi: 10.1016/j.joen.2009.09.003.

Reference Type BACKGROUND
PMID: 20003932 (View on PubMed)

Other Identifiers

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452/HD-DHYD

Identifier Type: -

Identifier Source: org_study_id

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